Lemtrada Side Effects

Generic name: alemtuzumab

Medically reviewed by Drugs.com. Last updated on Feb 1, 2024.

Note: This document provides detailed information about Lemtrada Side Effects associated with alemtuzumab. Some dosage forms listed on this page may not apply specifically to the brand name Lemtrada.

Applies to alemtuzumab: intravenous solution.

Important Warnings This medicine can cause some serious health issues

Intravenous route (Solution)

Cytopenias, Infusion-related Reactions, and Infections Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur.Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia.Escalate dose gradually and monitor patients during infusion.

Withhold therapy for Grade 3 or 4 infusion-related reactions.Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections.

Intravenous route (Solution)

Autoimmunity, Infusion Reactions, Stroke, and Malignancies Alemtuzumab causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease.

Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last does of alemtuzumab.Alemtuzumab causes serious and life-threatening infusion reactions.

Alemtuzumab must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions.

Monitor patients for two hours after each infusion.

Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of alemtuzumab administration.

Instruct patients to seek immediate medical attention if symptoms of stroke occur.Alemtuzumab may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders.

Perform baseline and yearly skin exams.Because of the risk of autoimmunity, infusion reactions, and malignancies, alemtuzumab is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program.

Call 1-855-676-6326 to enroll in the alemtuzumab REMS program.

Serious side effects of Lemtrada

Along with its needed effects, alemtuzumab (the active ingredient contained in Lemtrada) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking alemtuzumab:

More common

• black, tarry stools
• blood in the urine
• chest tightness
• chills
• cough
• diarrhea
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• fever
• headache
• itching, hives, skin rash
• nausea
• painful or difficult urination
• pale skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• bloating or swelling of the face, hands, lower legs, or feet
• chest pain
• hoarseness
• lower back or side pain
• muscle weakness
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pounding or irregular heartbeat or pulse
• rapid weight gain
• red or purple spots on the skin, varying in size and remaining after pushing the skin surface
• tremor
• unexplained nosebleeds

Rare

• bloody nose
• flushing of the face or neck
• swelling of the eyelids, face, or lips
• white patches on the tongue, in the mouth, or in the folds of the skin, including the genitals

Incidence not known

• anxiety
• back pain
• blindness
• blurred or double vision
• chest pain or discomfort
• confusion
• dark urine
• decreased urine output
• decreased vision
• difficulty in speaking
• dilated neck veins
• discouragement
• double vision
• drowsiness
• extreme tiredness or weakness
• eye pain
• feeling of discomfort
• feeling sad or empty
• general feeling of tiredness and weakness
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular breathing
• irritability
• joint pain, stiffness, or swelling
• lack of appetite
• light-colored stools
• loss of interest or pleasure
• muscle aches or pain
• nightmares or unusually vivid dreams
• numbness, pain, tingling, or weakness
• pain or discomfort in the arms, jaw, back, or neck
• painful or tender lymph glands in the neck, armpit, or groin
• seizures
• shakiness and unsteady walk
• slow speech
• spitting or coughing up blood
• stiff neck
• sudden numbness and weakness in the arms and legs
• swelling of the face, fingers, feet, or lower legs
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• upper right abdominal or stomach pain and fullness
• yellow eyes and skin

Other side effects of Lemtrada

Some side effects of alemtuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• fear or nervousness

Less common

• belching
• bone pain
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• heartburn
• indigestion
• lack or loss of strength
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• weight loss

Rare

• constipation
• sensation of temperature change
• sleepiness
• stuffy nose

For Healthcare Professionals

Applies to alemtuzumab: intravenous solution.

Hematologic

• Very common (10% or more): Lymphopenia (97%), neutropenia (77%), anemia (76%), thrombocytopenia (71%), granulocytopenia
• Common (1% to 10%): Decrease in CD4 lymphocytes, decrease in CD8 lymphocytes, decrease in T-lymphocyte count, febrile neutropenia, pancytopenia, leukopenia, lymphopenia, purpura
• Uncommon (0.1% to 1%): Aplasia bone marrow, disseminated intravascular coagulation, hemolytic anemia, decreased haptoglobin, bone marrow depression, hematology test abnormal^[Ref]

Immunologic

• Very common (10% or more): Immunogenicity (up to 83%), herpes viral infection (16%), fungal infection (13%), sepsis, cytomegalovirus infection, cytomegalovirus
• viremia
• Common (1% to 10%): Influenza, neutropenic fever
• Uncommon (0.1% to 1%): Sepsis, staphylococcal bacteremia, tuberculosis, beta hemolytic streptococcal infections, candidiasis, genital candidiasis, body tinea
• Very rare (less than 0.01%): Immune thrombocytopenia
• Frequency not reported: Autoimmunity^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (25%), upper respiratory tract infection (16%), sinusitis (11%), pneumonia
• Common (1% to 10%): Cough, dyspnea, bronchitis, chest discomfort, epistaxis, hypoxia, hemoptysis, bronchospasm
• Uncommon (0.1% to 1%): Stridor, throat tightness, pulmonary infiltration, pleural effusion, breath sounds decreased, respiratory disorder
• Frequency not reported: Respiratory alkalosis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (21%), diarrhea (12%), oropharyngeal pain (11%), abdominal pain (10%), vomiting (10%)
• Common (1% to 10%): Dyspepsia, gastrointestinal hemorrhage, ulcerative stomatitis, stomatitis, gastroenteritis, tongue ulceration, gingivitis, hiccup, eructation, dyspepsia, constipation, flatulence, oral candidiasis
• Uncommon (0.1% to 1%): Gingival bleeding, dry mouth, paralytic ileus, oral discomfort
• Frequency not reported: Duodenal ulcer, intestinal perforation, melena, peptic ulcer, pseudomembranous colitis, colitis, pancreatitis, peritonitis^[Ref]

Nervous system

• Very common (10% or more): Headache (52%), insomnia (16%), paresthesia (10%), dizziness (10%)
• Common (1% to 10%): Dysgeusia, vertigo, tremor, paresthesia, hypoesthesia, hyperkinesia, taste loss
• Uncommon (0.1% to 1%): Syncope, abnormal gait, dystonia, hyperesthesia, neuropathy, taste perversion^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension, hypertension
• Common (1% to 10%): Tachycardia, peripheral edema, vasospasm
• Uncommon (0.1% to 1%): Cardiac arrest, myocardial infarction, atrial fibrillation, supraventricular tachycardia, arrhythmia, bradycardia, abnormal ECG, peripheral ischemia, cyanosis, orthostatic hypotension, hot flush
• Frequency not reported: Congestive heart failure, cardiomyopathy, decreased ejection fraction in non-MS patients previously treated with potentially cardiotoxic agents^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (12%), pain in extremity (12%), back pain (12%)
• Common (1% to 10%): Chills, muscular weakness, muscle spasms, myalgia, neck pain, arthralgia, skeletal pain, back pain
• Uncommon (0.1% to 1%): Leg pain, hypertonia, muscle spasms
• Frequency not reported: Arthritis or worsening arthritis, bone fracture, myositis, muscle atrophy, osteomyelitis, polymyositis, skeletal pain^[Ref]

Dermatologic

• Very common (10% or more): Rash (53%), urticaria (16%), pruritus (14%)
• Common (1% to 10%): Dermatitis, erythema, hyperhidrosis, bullous eruption, erythematous rash
• Uncommon (0.1% to 1%): Maculopapular rash, skin disorder^[Ref]

Endocrine

• Very common (10% or more): Thyroid gland disorders (13%)^[Ref]

Hepatic

• Frequency not reported: Hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, biliary pain^[Ref]

Metabolic

• Very common (10% or more): Anorexia
• Common (1% to 10%): hyponatremia, hypocalcemia, weight decrease, dehydration, thirst
• Uncommon (0.1% to 1%): Hypokalemia, diabetes mellitus aggravated
• Frequency not reported: Thyroid disorder, fluid overload^[Ref]

Oncologic

• Frequency not reported: Malignancies (e.g., malignant lymphoma, malignant testicular neoplasm, prostatic cancer, plasma cell dyscrasias, secondary leukemia, squamous cell carcinoma)^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (19%)
• Common (1% to 10%): Blood in urine, abnormal uterine bleeding
• Uncommon (0.1% to 1%): Impotence, urinary incontinence, urine flow decreased, polyuria, cystitis
• Frequency not reported: Cervical dysplasia^[Ref]

Other

• Very common (10% or more): Pyrexia (29%), fatigue (18%), flushing (10%)
• Common (1% to 10%): Asthenia^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal function abnormal
• Frequency not reported: Acute renal failure^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Uncommon (0.1% to 1%): Endophthalmitis^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Allergic reaction
• Frequency not reported: Anaphylactoid reaction^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion site bruising, infusion site dermatitis, infusion site pain
• Frequency not reported: Infusion reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), hypoxia, syncope, acute respiratory distress syndrome, respiratory arrest, myocardial infarction, acute cardiac insufficiency, cardiac arrest, transient neurologic symptoms, hypertension, headache, pyrexia, rash, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, pain)^[Ref]

Frequently asked questions

• What are the new drugs used for multiple sclerosis (MS)?

Further information

Lemtrada side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer